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Acceptability Study of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Type 2 Diabetes and Dyslipidemia

This study has been completed.
Information provided by:
Solvay Pharmaceuticals Identifier:
First received: June 21, 2007
Last updated: August 31, 2007
Last verified: August 2007
The present study aims to assess the acceptability of a 4 week treatment of a new fixed-dose combination of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Fenofibrate 80 mg and metformin 1000 mg (fixed combination)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Multicenter Trial Assessing the Acceptability of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Patients With Type 2 Diabetes and Dyslipidemia

Resource links provided by NLM:

Further study details as provided by Solvay Pharmaceuticals:

Enrollment: 29
Study Start Date: March 2007

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female patients aged from 20 to 80 years (at inclusion visit).
  2. Type 2 diabetes treated with a stable dose of metformin for a minimum of 3 months either alone or in combination with another oral hypoglycaemic agent.
  3. Dyslipidemia treated with 160 mg fenofibrate (or bioequivalent formulations) for a minimum of 3 months either alone or in combination with a statin.
  4. And having signed a written informed consent.-

Exclusion Criteria:

  1. Known Type 1 Diabetes, uncontrolled type 2 diabetes [HbA1c > 9.5 %, Fasting plasma glucose (FPG) > 240 mg/dL (> 13.4 mmol/L) on the last performed blood sample (within the last 3 months)].
  2. TG > 500 mg/dL (> 5.65 mmol/L) on the last performed blood sample (within the last 3 months).
  3. Women who are not surgically sterilized (i.e. bilateral tubal ligation, bilateral or two unilateral oophorectomies, hysterectomy) or not using adequate contraceptive methods (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide) or not postmenopausal (> 1 year since their last menstrual period).
  4. Pregnant or lactating women.
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Please refer to this study by its identifier: NCT00490178

Site 3
Marseille, France
Site 1
Nantes, France
Site 2
Tours, France
Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information Identifier: NCT00490178     History of Changes
Other Study ID Numbers: C LF23-0121 06 02
Study First Received: June 21, 2007
Last Updated: August 31, 2007

Keywords provided by Solvay Pharmaceuticals:
Type II diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Hypoglycemic Agents
Physiological Effects of Drugs
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents processed this record on April 27, 2017